Clinical trials: Endovascular Aortic Repair
Juxtarenal Aortic Aneurysm, Pararenal Aneurysm
Comparison of Outcomes of Complex Abdominal Aortic Aneurysm Treatment
Background: Open repair remains the gold standard for fit patients with complex AAA. In the past decade, an evolution of devices, design, components, and delivery systems expanded the application of EVAR in these challenging…
- Trial name
- NCT04773223
- Testing
- Open surgery and complex EVAR due to AAA
- Where
- Serbia
- Volunteers
- 925 people
- Sponsor
- Clinical Centre of Serbia
Aortic Aneurysm, Thoracic, Chronic Type B Dissection
Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending TAA and Chronic Dissections
The purpose of the Feasibility study is to characterize the safety of the Valiant Mona LSA Thoracic Stent Graft System, including an assessment of the safety and effectiveness of the device acutely and at the 30 day visit in the…
- Trial name
- NCT02365467
- Testing
- Valiant Mona LSA Thoracic Stent Graft System
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Medtronic Cardiovascular
Abdominal Aortic Aneurysm
Immediate Management of the Patient With Rupture : Open Versus Endovascular Repair
The purpose of this trial is to assess whether a strategy of endovascular repair (if aortic morphology is suitable, open repair if not) versus open repair reduces early mortality for patients with suspected ruptured abdominal…
- Trial name
- IMPROVE (NCT00746122)
- Testing
- Open repair, EVAR
- Where
- 30 sites in Canada, United Kingdom
- Volunteers
- 613 people
- Sponsor
- Imperial College London
Abdominal Aortic Aneurysm
Safety and Effectiveness Trial of the Ventana Fenestrated Stent Graft System
The purpose of this trial is to determine if the Ventana Fenestrated Stent Graft System is safe and effective for the endovascular repair of juxtarenal or pararenal aortic aneurysms.
- Trial name
- NCT01491945
- Testing
- Ventana Fenestrated Stent Graft System
- Where
- 22 sites in United States
- Volunteers
- 76 people
- Sponsor
- Endologix
Blunt Thoracic Aortic Injury
Study to Determine if the Valiant Stent Graft is Safe and Effective in Treating Patients Who Have a Blunt Thoracic Aortic Injury
The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a blunt thoracic aortic injury (BTAI).
- Trial name
- RESCUE (NCT01092767)
- Testing
- Valiant Thoracic Stent Graft with the Captivia Delivery System
- Where
- 25 sites in United States, Canada
- Volunteers
- 50 people
- Sponsor
- Medtronic Cardiovascular
Aortic Aneurysm, Abdominal
Post-Approval Trial of the Talent™ Abdominal Stent Graft to Treat Aortic Aneurysms
The purpose of this study is to examine, through the endpoints established in this protocol, the long-term safety and effectiveness of the Talent Abdominal Stent Graft System, in a post-approval environment.
- Trial name
- VITALITY (NCT00816062)
- Testing
- Talent Abdominal Stent Graft
- Where
- 18 sites in United States
- Volunteers
- 94 people
- Sponsor
- Medtronic Cardiovascular
Abdominal Aortic Aneurysms
European (EU) Post Approval Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms
INSIGHT is a postmarket clinical follow-up study in the European Union. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of INCRAFT in subjects with abdominal aortic aneurysms requiring…
- Trial name
- INSIGHT (NCT02477111)
- Testing
- Endovascular abdominal aortic aneurysm repair
- Where
- 23 sites in France, Germany and 6 more
- Volunteers
- 150 people
- Sponsor
- Cordis US Corp.
Abdominal Aortic Aneurysm (AAA)
Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System
The objective of this study is to assess the safety and effectiveness of the Endologix Nellix® System for the endovascular repair of infrarenal abdominal aortic aneurysms (AAA).
- Trial name
- EVAS1 (NCT01726257)
- Testing
- Nellix System
- Where
- 30 sites in United States, Germany and 2 more
- Volunteers
- 333 people
- Sponsor
- Endologix
Descending Thoracic Aortic Aneurysm
Zenith TX2® Post-market Approval Study
The Zenith TX2® Post-market Approval Study is a clinical trial approved by US FDA to further study the safety and effectiveness of the Zenith TX2® TAA Endovascular Graft in the treatment of thoracic aortic aneurysms.
- Trial name
- TX2 2PAS (NCT00813358)
- Testing
- Zenith TX2® TAA Endovascular Graft
- Where
- 25 sites in United States, Canada
- Volunteers
- 115 people
- Sponsor
- Cook Research Incorporated
Abdominal Aortic Aneurysm
Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices
The objective of this post-market trial is to evaluate Endologix AFX endovascular AAA system with anatomical fixation against other approved Endovascular systems with proximal fixation.
- Trial name
- LEOPARD (NCT02407457)
- Testing
- AFX EVAR AAA Graft System, FDA Approved EVAR AAA Graft Systems
- Where
- 56 sites in United States
- Volunteers
- 455 people
- Sponsor
- Endologix
Aortic Aneurysm, Abdominal
Impact of Grafts and Endografts for Abdominal Aneurysms on Arterial Stiffness.
The purpose of this study is to evaluate by non-invasive methods the change in central hemodynamics and arterial stiffness produced by grafts and endografts after abdominal aortic aneurysm repair.
- Trial name
- NCT02642952
- Testing
- non-invasive methods
- Where
- Spain
- Volunteers
- 52 people
- Sponsor
- Hospital Universitario Ramon y Cajal
Abdominal Aortic Aneurysm
Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System
The aim of this study is to evaluate the safety and feasibility of the Endologix Fenestrated Stent Graft System for the endovascular repair of juxtarenal or pararenal aortic aneurysms.
- Trial name
- NCT01348828
- Testing
- Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)
- Where
- 8 sites in United States, Chile and 4 more
- Volunteers
- 49 people
- Sponsor
- Endologix
Endoleaks
Evaluation of Contrast-Enhanced Ultrasound to Detect Endoleaks After Endovascular Aortic Aneurysm Repair
This study will be a cross-sectional survey of interobserver variability associated with contrast enhanced ultrasound (CEUS) to detect endoleaks using computed tomographic angiography (CTA) as the practice standard.
- Trial name
- AAA CEUS (NCT01005212)
- Testing
- Definity
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- E. Peden, MD
Abdominal Aortic Aneurysm Without Rupture
EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study
Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.
- Trial name
- EVAS2 (NCT03298477)
- Testing
- Nellix® System
- Where
- 27 sites in United States
- Volunteers
- 98 people
- Sponsor
- Endologix
Abdominal Aortic Aneurysms (AAA)
The Pivotal Study of the Aptus Endovascular AAA Repair System
A prospective, non-randomized, multi-center clinical study to evaluate the safety and effectiveness of the Aptus Endovascular AAA Repair System compared to an open surgical repair historical control group in the treatment of…
- Trial name
- STAPLE-2 (NCT00507559)
- Testing
- Aptus Endovascular AAA Repair System
- Where
- 2 sites in United States
- Volunteers
- 155 people
- Sponsor
- Medtronic Cardiovascular
Abdominal Aortic Aneurysm
Preferences for Open Vs. Endovascular Repair for Abdominal Aortic Aneurysm
This study tests the use of a decision aid for Veterans who are facing a decision about surgery for their Abdominal Aortic Aneurysm (AAA).
- Trial name
- PROVE-AAA (NCT03115346)
- Testing
- Decision aid
- Where
- 22 sites in United States
- Volunteers
- 241 people
- Sponsor
- VA Office of Research and Development
Aortic Dissection
Study to Evaluate the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System (Valiant Captivia) for the Treatment of Acute, Complicated Type B Aortic Dissections
The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a thoracic dissection.
- Trial name
- NCT01114724
- Testing
- Valiant Thoracic Stent Graft with the Captivia Delivery System
- Where
- 17 sites in United States
- Volunteers
- 50 people
- Sponsor
- Medtronic Cardiovascular
Abdominal Aortic Aneurysms
A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With AAA (INNOVATION)
This study is a multi-center prospective, open label, non-randomized investigation of INCRAFT™ in subjects with abdominal aortic aneurysms. The study will enroll up to 60 subjects in up to 7 sites in Germany and Italy.
- Trial name
- INNOVATION (NCT01106391)
- Testing
- Cordis AAA stent graft system "INCRAFT TM"
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Cordis US Corp.
Type B Aortic Dissection
LSA Reconstruction With Laser Fenestration During the TEVAR
This study aims to evaluate the feasibility, effectiveness, and safety of in-situ laser-assisted fenestration on the left subclavian artery during the procedure of thoracic artery endovascular repair
- Trial name
- LLTEVAR (NCT03845829)
- Testing
- In situ laser assisted fenestration
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Thoracic Aortic Aneurysm
Valor II: The Valiant Thoracic Stent Graft System Clinical Study
This study was designed to study safety and effectiveness of the Valiant Thoracic Stent Graft to treat thoracic aortic aneurysms.
- Trial name
- NCT00413231
- Testing
- Valiant Thoracic Stent Graft System
- Where
- 26 sites in United States
- Volunteers
- 160 people
- Sponsor
- Medtronic Cardiovascular